A Phase I, randomized, consecutive dose, double blind, parallel study comparing the PK, PD, immunogenicity, safety and tolerability of LB-0702 and Nplate® in healthy volunteers.

Start 2 Jul 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol RJ-ROM02

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Bioequivalence study

Status Ongoing, recruiting

Participants planned 106

Countries 1

Sites 2

Not applicable (submitted trial is a bioequivalence study)

Key facts

Sponsor: Laboratorio Reig Jofre S.A.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male
Therapeutic area: Not possible to specify
Trial duration: 2 Jul 2025 → ongoing
Decision date (initial): 2025-03-18
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Not applicable (submitted trial is a bioequivalence study)

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratorio Reig Jofre S.A.

Sponsor organisation: Laboratorio Reig Jofre S.A.
Address: Avinguda Les Flors S/N
City: Sant Joan Despi
Postcode: 08970
Country: Spain

Scientific contact point

Organisation: Laboratorio Reig Jofre S.A.
Contact name: Mohammed Sharaf

Public contact point

Organisation: Laboratorio Reig Jofre S.A.
Contact name: Mohammed Sharaf

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Ongoing, recruiting	106	2
Rest of world	—	0	—

Investigational sites

Spain

2 sites · Ongoing, recruiting

Hospital Universitario De La Princesa

Unidad de Ensayos Clínicos Fase I, Calle De Diego De Leon 62, 28006, Madrid

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Institut de Recerca - CIM-Sant Pau, Calle Sant Quinti 77-79, 08041, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Spain	2025-07-02		2025-07-28

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-11-29	Spain	Acceptable 2025-03-08	2025-03-18
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-07-11	Spain	Acceptable 2025-03-08	2025-07-11